By Richard Gliklich, MD, Founder, OM1 A Historical Perspective on Registries In 2005, I had the honor of leading the first Agency for Healthcare Research and Quality (AHRQ) effort to develop a handbook on patient registries. The impetus for the handbook, which we published in 2007, was the growing need to demonstrate real-world safety, effectiveness,[…]
By OM1 | February 2025 Hidradenitis Suppurativa (HS) is a chronic and debilitating skin condition that presents significant challenges for patients and healthcare providers alike. Many patients suffer for years without an accurate diagnosis, causing painful nodules on the skin to worsen over time. HS is often associated with systemic mental health, immunologic, and cardiometabolic[…]
In the rapidly evolving landscape of clinical trials, data collection remains one of the most time-consuming and cost-intensive processes. For decades, the manual abstraction of clinical data into electronic case report forms (eCRFs) has been the predominant method for gathering information from trial participants. This paradigm, largely unchanged since the 1990s, remains resource- intensive and[…]
Rheumatologic diseases like systemic lupus erythematosus (SLE), ankylosing spondylitis, and rheumatoid arthritis can present significant challenges for biopharma. These conditions are chronic, complex, and multisystemic. While traditional clinical trials provide essential insights, they often fail to capture the full spectrum of patient experiences or reflect the diversity seen in real-world populations. Real-world data (RWD), combined[…]
By Vadim Pinsky, PhD, and Gabe Goldfeder, M.A. One of the key frameworks for understanding data analytics in Real-World Evidence (RWE) is the “Five Vs”: Velocity, Volume, Variety, Veracity, and Value. Each aspect plays a crucial role in the data collection and analysis process, shaping how efficiently and accurately insights are generated. For healthcare professionals,[…]
